Ardea Biosciences Identifies Lead Development Candidate for Gout, RDEA594

... - RDEA594 Data to Be Presented at the 2008 Annual European Congress... 2008 - ...SAN DIEGO May 19 /- Ardea Biosciences Inc.(N...Based on extensive in vitro and in vivo experiments the Companybelie...

- RDEA594 Data to Be Presented at the 2008 Annual European Congress of
Rheumatology Organized by the European League Against Rheumatism (EULAR) -
- Initiation of Phase 1 Human Study of RDEA594 Planned in Second Half of

2008 -

SAN DIEGO, May 19 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc.
(Nasdaq: RDEA) today announced the identification of its lead development
candidate for the treatment of patients with gout, RDEA594. Gout is a
painful and debilitating disease that is caused by abnormally elevated
levels of uric acid in the blood stream. RDEA594 is a major metabolite in
both humans and animals of RDEA806, the Company's lead human
immunodeficiency virus (HIV) development candidate. RDEA594 does not have
significant antiviral activity, but is believed to be responsible for
essentially all of the uric acid lowering effects seen with RDEA806. Robust
uric acid-lowering effects have been observed following administration of
RDEA806 in Phase 1 and Phase 2 clinical trials that included over 100
subjects.

Based on extensive in vitro and in vivo experiments, the Company
believes it has elucidated the mechanism by which RDEA594 lowers serum uric
acid levels. RDEA594 exhibits a concentration-dependent inhibitory effect
on the URAT1 transporter-mediated uptake of uric acid ex vivo and increases
uric acid excretion in animal models. These effects are believed to result
in the lowering of serum uric acid observed with RDEA806. URAT1 is a
specific urate transporter expressed in the kidney responsible for
regulation of uric acid levels, and is a validated target for treatment of
hyperuricemia and gout.

"Gout represents a major medical challenge in the United States and
throughout the world, with millions of people affected by this debilitating
condition," said Barry D. Quart, PharmD, Ardea Biosciences' President and
CEO. "With the designation of RDEA594 as our clinical candidate for the
treatment of gout, we now expect to have five novel candidates in clinical
testing during the second half of 2008, positioning us with the potential
to have a broad-based, late-stage pipeline in 2009. This finding also
allows us to focus our future development efforts with RDEA806 on the
treatment of HIV."

The Company plans to initiate a Phase 1 clinical study of RDEA594 in
the second half of this year. As previously announced, the Company also
plans to conduct a Phase 2 proof-of-concept clinical study in patients with
gout, to confirm RDEA594's activity in the target population using its
prodrug, RDEA806. This study is on track to be initiated in the second
quarter of this year.

An estimated 3-5 million people in the United States suffer from gout,
which is the most common form of inflammatory arthritis in men over 40.
Gout, also known as metabolic arthritis, is a painful and debilitating
disease caused by abnormally elevated levels of uric acid in the blood
stream. These abnormally elevated levels lead to the deposition of uric
acid crystals in and around the connective tissue of the joints and in the
kidneys, leading to inflammation, the formation of disfiguring nodules
(tophi), intermittent attacks of severe pain (acute flares), and kidney
damage (nephropathy). While gout is a treatable condition, there are
limited treatment options, and a number of adverse effects are associated
with current therapies. No new therapies have been approved by the FDA for
the treatment of hyperuricemia associated with gout in the past 40 years.

About RDEA594

RDEA594 is a development candidate that has potential for treating gout
patients with hyperuricemia. RDEA594 is a metabolite of RDEA806, a
non-nucleoside reverse transcriptase inhibitor (NNRTI) in development for
the treatment of HIV. In Phase 1 studies with RDEA806 in healthy
volunteers, increased urinary excretion of uric acid was observed in the
first 24 hours after dosing, with statistically significant,
exposure-dependent, decreases in serum uric acid of 35% to 50% observed
following 10-14 days of dosing. RDEA594 exhibits a concentration-dependent
inhibitory effect on the URAT1-mediated uptake of uric acid ex vivo and is
believed to be the active moiety responsible for the uric acid-lowering
effects of RDEA806. Approximately 90% of hyperuricemic patients are
considered to be under-excretors of uric acid, so increasing excretion may
provide the most physiologically appropriate treatment. RDEA594 does not
have significant antiviral activity.

About Ardea Biosciences

Ardea Biosciences, Inc., of San Diego, California, is a biotechnology
company focused on the discovery and development of small-molecule
therapeutics for the treatment of HIV, cancer and inflammatory diseases,
including gout. We have four drug candidates in clinical trials and others
in preclinical development and discovery. Our most advanced development
candidate is RDEA806, a non-nucleoside reverse transcriptase inhibitor
(NNRTI), which is in a Phase 2a study for the treatment of HIV. We have
evaluated our second-generation NNRTI for the treatment of HIV, RDEA427, in
a human micro-dose pharmacokinetic study and have selected it as a
development candidate. RDEA594, our lead development candidate for the
treatment of gout, is in preclinical development and is believed to be an
inhibitor of the URAT1 transporter in the kidney, which is responsible for
regulation of uric acid levels. We are evaluating our lead MEK inhibitor,
RDEA119, in a Phase 1 study in advanced cancer patients, as well as in a
Phase 1 study in normal healthy volunteers as a precursor to trials in
patients with inflammatory diseases. Lastly, we have evaluated our
second-generation MEK inhibitor for the treatment of cancer and
inflammatory diseases, RDEA436, in a human micro-dose pharmacokinetic study
and have selected it as a development candidate.

Statements contained in this press release regarding matters that are
not historical facts are "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results may
differ materially from those expressed or implied by such forward-looking
statements. Such statements include, but are not limited to, statements
regarding our goals, including the expected properties and benefits of
RDEA806, RDEA427, RDEA594, RDEA119, RDEA436 and our other compounds and the
results of preclinical, clinical and other studies. Risks that contribute
to the uncertain nature of the forward-looking statements include: risks
related to the outcome of preclinical and clinical studies, risks related
to regulatory approvals, delays in commencement of preclinical and clinical
studies, and costs associated with internal development and business
development activities. These and other risks and uncertainties are
described more fully in our most recently filed SEC documents, including
our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q,
under the headings "Risk Factors." All forward-looking statements contained
in this press release speak only as of the date on which they were made. We
undertake no obligation to update such statements to reflect events that
occur or circumstances that exist after the date on which they were made.

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